Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00195910
Status:
COMPLETED
Last Update Posted:
2018-08-15
First Post:
2005-09-12
Brief Title:
Safety and Efficacy Study of Hydromorphone and Morphine
Sponsor:
Montefiore Medical Center
Organization:
Montefiore Medical Center
Study Overview
Official Title:
Safety and Efficacy of Hydromorphone as an Analgesic Alternative to Morphine in Acute Severe Pain A Randomized Clinical Trial
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To compare a standard weight-based dose of intravenous IV hydromorphone Dilaudid to a standard weight-based dose of IV morphine in adults presenting to the Emergency Department ED with acute severe pain
Detailed Description:
There is widespread agreement that pain is under-treated in the Emergency Department ED The current recommended treatment of acute pain in the ED setting is administration of an initial bolus of morphine followed by titration until adequate analgesia is achieved Several studies have shown that even 01 mgkg IV morphine 7-10 mg administered to the average 70-100 kg patient inadequately treats many patients acute pain In spite of this it has been observed that many emergency physicians and nurses are hesitant to give 7-10 mg of morphine as an initial IV dose In contrast it has been observed that these same healthcare providers were not similarly reluctant to administer a roughly equianalgesic dose of hydromorphone 1-15 mg perhaps because the more potent hydromorphone is given in much smaller milligram quantities than morphine thus providing the illusion of substantially less opioid administered to the patient Having repeatedly observed this phenomenon it is reasonable that if a smaller milligram dose of hydromorphone were shown to provide an efficacy safety and side-effect profile comparable or superior to a larger milligram dose of morphine it would provide evidence supporting use of hydromorphone as an alternative first line opioid in the treatment of acute pain presenting to the ED As a practical corollary to this it is reasoned further that the increased willingness of healthcare providers to use hydromorphone might contribute to reducing one component of the multifaceted problem of oligoanalgesia in the ED
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None